Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089029
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/17/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1998 SUPPL-8 Labeling

Label is not available on this site.

12/09/1991 SUPPL-6 Labeling

Label is not available on this site.

11/07/1988 SUPPL-5 Labeling

Label is not available on this site.

03/04/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/03/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/05/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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